Health Canada has posted a recall of two Innovacon pregnancy tests, saying the devices may show a positive result in people who are not pregnant.
The recall covers all lots of the Innovacon hCG One Step Pregnancy Test Device (Urine/Serum), Model FHC-202, and the hCG One Step Pregnancy Test Strip (Urine), Model FHC-101. The manufacturer is Innovacon, Inc., based in San Diego, California.
Health Canada’s recall notice, first published Oct. 2, 2026, and updated Oct. 5, said the tests may detect levels of the pregnancy hormone hCG that fall below the sensitivity the company states for the product. That can lead to a false positive result.
The notice lists the recall date as Sept. 21, 2026. Health Canada classified it as a Type II recall and gave it the identification number RA-82718.
A Type II recall generally involves products that may cause a temporary health problem or a slight risk of a serious one. Health Canada did not describe any injuries or complaints in the notice.
The manufacturer is updating the package inserts for the tests. The new wording says low hCG levels can occur at or after the onset of perimenopause, which may matter when a result is read. The notice said the recall is aimed at healthcare audiences and concerns the performance of the devices.
Health Canada’s recommended action for the public is to contact the manufacturer if more information is needed. The notice gave a mailing address for Innovacon, Inc. at 9942 Mesa Rim Road, San Diego, California 92121.
The notice did not say how many tests were sold in Canada or which retailers or clinics carried them. It also did not say the products should be thrown out. People who have one of the affected models can compare the model number on the box or device with the two listed above.
Home pregnancy tests detect hCG in urine. A false positive means the test shows a positive result when the person is not pregnant. Health Canada said the concern with these two models is that they may react to hormone levels lower than the company says they should.
The perimenopause note in the updated package insert points to a separate issue. Hormone levels can vary in the years leading up to menopause, and the manufacturer said low hCG levels may be present in that stage of life. The notice did not say how often that has caused a misleading result with these tests.
Health Canada’s Recalls and Safety Alerts database lists the full notice. Anyone with questions about a specific test result can speak with a doctor, nurse practitioner or pharmacist, who can explain next steps.
This article is based on official guidance from Health Canada and is provided for general public information. It’s not a substitute for medical advice, if you have questions about how this applies to you, talk to your doctor or pharmacist.
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Sources: Health Canada, hCG One Step Pregnancy Tests recall (RA-82718)
